Effects of Empowerment Program Integrated With Family Support on Maternal Self-esteem and Quality of Life Among Palestinian Pregnant Adolescents

November 15, 2023 updated by: Shurouq Ghalib Mousa Qadous, Prince of Songkla University

The Effects of Empowerment Program Integrated With Family Support on Maternal Self-Esteem and Quality of Life Among Pregnant Adolescents in Palestine: A Randomized Controlled Trial

Adolescent pregnancy leads to increase risks and complications for the adolescent mother and her newborn. This study aims to examine the effects of empowerment program integrated with family support on maternal self-esteem and quality of life among Palestinian pregnant adolescents. A randomized controlled single-blind trial, pretest-posttest controlled group design will be conducted with 62 participants ( control group =31, experimental group = 31). Research instruments will include the instruments for data collection, instruments for research intervention, and control instruments for intervention evaluation. The instruments for data collection will be consists of a demographic data form, Maternal Self-Report Inventory (MSRI), and WHO quality of life-BREF (WHOQoL-BREF, 1997). The empowerment program integrated with family support will be the research intervention instruments and included five steps; step 1: building relationships and creating collaboration, step 2: discovering reality, step 3: critical reflection, step 4: taking charge, and step 5: holding on. Control instruments through Family Support Questionnaire (FSQ) will be used to evaluate the effectiveness of the intervention program. Data will be analyzed using mean and standard deviations, frequency distribution, percentage, and chi-square test, and t-test. This program is expected to guide nurses to empower pregnant adolescents in enhancing maternal self-esteem and improve their quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
71

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age from 15 to 20 years.
  2. First-time pregnant.
  3. Have a single fetus.
  4. Gestational age 32 or 33 weeks.
  5. Medical history free from diseases such as diabetes mellitus (DM), hypertension, urinary tract infections (UTIs), heart disease, and thyroid disease.
  6. Free of complications during the present pregnancy such as preterm labor and gestational hypertension.
  7. Have more than check answers on the perinatal screening depression checklist (adopted from Edinburgh Postnatal Depression Scale).
  8. Having their own family member (pregnant adolescents' husband, own mother, mother-in-law, her sister, or sister-in-law) during giving the intervention.
  9. Able to read, write, and communicate clearly in the Arabic language.
  10. Living in Nablus City.

The family member will be included in any of the following criteria are present.

  1. Being with the pregnant adolescent during the intervention and continue giving support at home.
  2. The available phone number for contact while family members are at home.

Exclusion Criteria:

  1. Pregnant adolescents who experience any serious obstetric complications during the study such as preterm labor, gestational hypertension, and bleeding disorders.
  2. Pregnant adolescent who is not able to follow or complete the intervention program.
  3. Family member who is unable to accompany the pregnant adolescent during the intervention delivery at the primary health care clinic.
  4. Family member who is unable to give social support to the pregnant adolescent at home.
  5. Pregnant adolescents or family members in case one of them withdraws from the study the other will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
For the control group, the researcher will provide routine care to pregnant adolescents.
Experimental: Experimental group
For the experimental group, the researcher will provide the empowered program integrated with family support plus routine care.
Other: Empowered program integrated with family support
The empowered program integrated with family support is an intervention consisted of five steps that will be given when pregnant adolescents on gestational age 32 or 33 weeks the second meeting will be when the pregnant adolescents on gestational age 34 or 35 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maternal Self-Esteem (MSE)
Time Frame: Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)
Used Maternal Self Report Inventory-Short Form (MSRI-SF)
Measure MSE at 32 weeks gestation or 33 weeks gestation (Preintervention)
Quality of Life (QoL)
Time Frame: Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)
Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
Measure QoL at 32 weeks gestation or 33 weeks gestation (Preintervention)
Maternal Self-Esteem (MSE)
Time Frame: Measure MSE at 36 weeks gestation or 37 weeks gestation (Postintervention)
Used Maternal Self Report Inventory-Short Form (MSRI-SF)
Measure MSE at 36 weeks gestation or 37 weeks gestation (Postintervention)
Quality of Life (QoL)
Time Frame: Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)
Used World Health Organization Quality of Life- BREF (WHOQoL-BREF)
Measure QoL at 36 weeks gestation or 37 weeks gestation (Postintervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prince of Songkla University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shurouq Qadous, Prince Songkla University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSU IRB 2021-St-Nur 009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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